Although the use of biopharmaceuticals is on the increase, a major challenge for their efficient formulation and design is associated with their inherent lack of room temperature stability during processing or product storage (shelf-life). Many products are marketed as liquid products which need refrigeration or low temperature storage. Whilst conventional precipitation methods as well as freeze and spray drying processes can be used these procedures are expensive and often involve complex operations, therefore new alternatives are required.
Supercritical fluid (SCF) technologies, and the incorporation of stabilising and other regulatory acceptable agents (FDA approved etc) during particle formation have been shown to be a attractive and viable alternative to the aforementioned more conventionally used processes. The SCF process has been proven in many cases, to be able to process room temperature stable, uniform particles that are capable of rapid reconstitution. This is due to a unique processing environment that is virtually free of denaturing sheer forces and surface tension.
It is also possible to create inhalable peptides for systemic delivery. The typical bioavailability in human studies is approximately 18%, prior to optimisation.
CrystecPharma's intellectual property strategy is to protect products, maintaining its technology platform and scale-up expertise as a trade secret.
We are keen to work with companies developing large molecule therapeutics who are facing challenges of poor reconstitution, cold chain or stability.
Miss Catherine Hunter
Business Development Manager
CrystecPharma applies the latest supercritical fluid (SCF) technologies to improve the design and performance of medicinesView profile
Clients in focus...